Secondary Manifestations of Arterial Disease - Influence of Cardiovascular Prognosis and Treatment Effect Predictions on Patient and Physician Decision-Making: a Three-armed, Blinded, Randomized Controlled Trial

Secondary Manifestations of Arterial Disease - Influence of Cardiovascular Prognosis and Treatment Effect Predictions on Patient and Physician Decision-Making: a Three-armed, Blinded, Randomized Controlled Trial - SMART-INFORM

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45689

Enrollment

264

Registered

2016-12-19

Start date

2017-02-19

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinically manifest atherosclerotic disease Atherosclerosis Cardiovascular disease

Interventions

The three-arms of this trial are: 1. Standard-communication practices only (Control Group) 2. Standard- communication practices plus personalized information on a. Prediction passport: 10-year ri

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion in the SMART study (NL45885.041.13) 2. Clinically manifest cardiovascular disease, such as a confirmed diagnosis or strong clinical suspicion of one of the following: coronary artery disease, cerebrovascular disease, peripheral artery disease. 3. Use of statin medication at baseline 4. 45-80 years of age 5. Rankin Scale

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Terminal malignancy or short life-expectancy 3. No follow-up possible 4. Inability to effectively communicate in Dutch 5. No informed consent (IC) signed 6. Baseline questionnaire not returned

Design outcomes

Primary

Measure	Time frame
Patient experience with decision-making, measured using the Decisional Conflict Scale (DCS), 1 month post-intervention.	—

Secondary

Measure	Time frame
1. Prolonged Improved Patient Decision-Making; Measured with Decisional Conflict Scale (DCS) questionnaire at 6 months 2. Self-reported medication adherence; Measured with the Brief Medication Questionnaire (BMQ) at 1, and 6 months 3. Patients* illness perceptions; Measured with Brief Illness Perception Questionnaire (IPQ) questionnaire; at 1 and 6 months 4. Understanding of therapy-effects; Measured with Understanding of Therapy questionnaire, designed for this study at 1 and 6 months 5. General practitioners* assessment of the intervention; Measured with questionnaire designed for this study at 1 month 6. Patient Activation; Measured with Patient Activation Measure (PAM) questionnaire at and 6 months 7. Patient Reported Shared Decision-Making, measured with the 9 -item Shared Decision Making Questionnaire (SDMQ9), 1 month post intervention. 8. Patient Perception of Statin Efficacy, measured using a visual analog scale at 1 and 6 months. 9. Quality of Life, Measured using the Short Form Survey 36 (SF-36) questionnaire at 6 months. 10. Serum LDL-c (mmol/L) levels, 6 months after intervention, as documented the primary Care Dossier (last observation carried forward)	—

Measure

Time frame

1. Prolonged Improved Patient Decision-Making; Measured with Decisional Conflict Scale (DCS) questionnaire at 6 months 2. Self-reported medication adherence; Measured with the Brief Medication Questionnaire (BMQ) at 1, and 6 months 3. Patients* illness perceptions; Measured with Brief Illness Perception Questionnaire (IPQ) questionnaire; at 1 and 6 months 4. Understanding of therapy-effects; Measured with Understanding of Therapy questionnaire, designed for this study at 1 and 6 months 5. General practitioners* assessment of the intervention; Measured with questionnaire designed for this study at 1 month 6. Patient Activation; Measured with Patient Activation Measure (PAM) questionnaire at and 6 months 7. Patient Reported Shared Decision-Making, measured with the 9 -item Shared Decision Making Questionnaire (SDMQ9), 1 month post intervention. 8. Patient Perception of Statin Efficacy, measured using a visual analog scale at 1 and 6 months. 9. Quality of Life, Measured using the Short Form Survey 36 (SF-36) questionnaire at 6 months. 10. Serum LDL-c (mmol/L) levels, 6 months after intervention, as documented the primary Care Dossier (last observation carried forward)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)